Methylprednisolone for Knee Arthritis

No longer recruiting at 1 trial location

Overseen By Ajay Premkumar, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Emory University

Disqualifiers: Significant injuries, Minors, Immune suppression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 6 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Medrol Dose Pak, a type of glucocorticoid that reduces inflammation, can decrease pain and nausea after knee replacement surgery. Researchers seek to discover if this treatment results in less pain and a reduced need for opioids in the weeks following surgery. Participants will receive either the Medrol Dose Pak or a standard treatment with a single dose of another medication. Individuals planning a total knee replacement due to knee arthritis may be suitable candidates. As a Phase 4 trial, this research focuses on understanding how this FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have pre-existing immune suppression, you may not be eligible to participate.

What is the safety track record for Methylprednisolone?

Research shows that methylprednisolone is generally safe for people with knee problems. Studies have found that it reduces pain and improves movement in those with knee osteoarthritis. Methylprednisolone has also been used safely and effectively for other conditions.

In past studies, patients noticed significant improvements in their symptoms over a few weeks. This suggests that methylprednisolone is not only effective but also safe for similar conditions.

Since this study is in the later stages, earlier research has usually demonstrated the treatment's safety. Methylprednisolone's use for other conditions provides additional information about its safety. Always consult your doctor about any concerns before joining a trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for knee arthritis, like NSAIDs or corticosteroid injections, generally focus on reducing inflammation and pain over extended periods. However, methylprednisolone, under study for this condition, offers a unique approach with its specific six-day dosing regimen. Unlike the standard single-dose approach with dexamethasone, this treatment involves a tapered dosage that starts with a higher dose and gradually decreases. Researchers are excited because this method could potentially offer more rapid and sustained relief by precisely managing inflammation, which may improve recovery times and overall outcomes for patients.

What is the effectiveness track record for Methylprednisolone in reducing pain and nausea after knee replacement surgery?

Research shows that methylprednisolone can reduce pain and improve movement in people with knee osteoarthritis. Studies have found that injections of this corticosteroid can relieve pain and improve knee symptoms for up to 12 weeks. This trial will evaluate the effectiveness of a perioperative Medrol dose, a form of methylprednisolone, in managing pain and reducing the need for opioids after knee replacement surgery. Participants in the experimental group will receive a specific course of Medrol over six days. This treatment reduces inflammation, which is the body's response to injury or infection but can cause pain and swelling if uncontrolled. Evidence supports using methylprednisolone after surgery, showing it works well in similar situations. ^{1 2 3 4 5}

Who Is on the Research Team?

Ajay Premkumar, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for patients aged 18 to 95 who are undergoing their first total knee replacement due to severe knee arthritis. It's not suitable for those with other conditions that might affect the surgery or recovery.

Inclusion Criteria

I am having a knee replacement due to arthritis.

Exclusion Criteria

Subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures

I have serious injuries to other bones or organs.

I am a minor and cannot legally consent for myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total knee replacement surgery followed by a 6-day course of Medrol Dose Pak or standard care with a single dose of dexamethasone

6 days

Daily monitoring for 7 days post-surgery

Follow-up

Participants are monitored for pain, nausea, range of motion, and opioid consumption for six weeks post-surgery

6 weeks

Regular clinic visits for evaluation

What Are the Treatments Tested in This Trial?

Interventions

• Methylprednisolone

Trial Overview The study tests if a short-term steroid medication called Medrol Dose Pak can reduce pain, nausea, and opioid use after knee replacement surgery compared to standard post-surgery care.

How Is the Trial Designed?

Group I: Experimental Group: Medrol Dose Experimental Treatment 1 Intervention

The perioperative Medrol dose treatment will consist of a course that lasts six days, with 24 milligrams administered on the first day, 20 milligrams on the second day, 60 milligrams on the third day, 12 milligrams on the fourth day, 8 milligrams on the fifth day, and 4 milligrams on the sixth day. Patients will then be followed up at the clinic for six weeks following their procedure to allow for clinical evaluation and to measure outcome variables.

Group II: Control Group: Standard of Care Active Control 1 Intervention

Patients in this group will receive a single intraoperative dose of 10 mg intravenous dexamethasone (control group, IV dexamethasone is standard of care).

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

Methylprednisolone acetate (Depo-Medrol) injections via epidural or intrathecal routes can effectively relieve diskogenic back pain and radiculopathy when conservative treatments have failed, particularly if symptoms have lasted less than three months.

Corticosteroid injections are less effective for patients with chronic symptoms lasting over three months or those who have previously undergone surgery, suggesting a limited window for optimal use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of diskogenic pain using epidural and intrathecal steroids. Brown, FW.[2019]

In a study of 901 patients with relapsing-remitting multiple sclerosis, methylprednisolone (MP) pulse therapy was administered with a mean frequency of 4 times, showing that the majority of patients received treatment multiple times, indicating its common use in managing acute exacerbations.

The study found that female patients were approximately 3.7 times more likely to seek MP pulse therapy compared to male patients, suggesting a gender difference in treatment-seeking behavior for MS management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary study related the incidence of methylprednisolone pulse therapy in patients visited multiple sclerosis clinic located at the isfahan kashani hospital. Tolou-Ghamari, Z., Shaygannejad, V., Ashtari, F.[2022]

Intramedullary injection of methylprednisolone acetate (Depo-Medrol) effectively treats unicameral cysts in children, as demonstrated in a rabbit model where the drug was injected into the tibia.

The study found that while serum levels of methylprednisolone rose quickly, indicating systemic absorption, there were no significant local histological changes such as fibroblastic proliferation or neovascularization, suggesting that the mechanism of action may not involve direct tissue alteration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The systemic and local effects of an intramedullary injection of methylprednisolone acetate in growing rabbits. Colville, MR., Aronson, DD., Prcevski, P., et al.[2019]

Inadvertent injection of methylprednisolone acetate into the eye during vitrectomy can lead to severe retinal toxicity, resulting in significant vision loss and complications such as retinal necrosis and optic nerve damage.

This case highlights the critical need for careful identification of medications during eye surgeries to prevent serious adverse effects associated with incorrect injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retinal necrosis secondary to inadvertent intravitreal methylprednisolone acetate (depo-medrol) injection during pars plana vitrectomy. Yonekawa, Y., Sun, G., D'Amico, DJ., et al.[2014]

A case of conjunctival necrosis occurred in an 82-year-old patient after an inadvertent subconjunctival injection of methylprednisolone following cataract surgery, highlighting a serious complication associated with this medication.

Methylprednisolone is not approved for use in the eye, and this incident underscores the risks of using unapproved medications in ophthalmic procedures, emphasizing the need for caution and adherence to approved treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conjunctival Necrosis due to Subconjunctival Methylprednisolone (Depo-Medrol™) Acetate Injection. van Zyl, LM., Hill, JJ.[2021]

The study found that the new high-dose (100 mg) methylprednisolone tablet has an absolute bioavailability of 82%, indicating it is effectively absorbed in the body when taken orally.

No adverse drug reactions were reported, and the tablet can safely substitute for intravenous methylprednisolone in high-dose therapy, as it produced expected changes in blood neutrophil counts without significant side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Absolute bioavailability of a new high dose methylprednisolone tablet formulation. Groenewoud, G., Hundt, HK., Luus, HG., et al.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5908555/

Intra-articular injection of methylprednisolone for reducing ... Intra-articular methylprednisolone injection was associated with an improved pain relief and physical function in patients with knee osteoarthritis.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10570668/

Corticosteroid Injections for Symptomatic Treatment ... Corticosteroid injections demonstrated clinically meaningful improvements in KOA symptoms over 12 weeks of follow‐up. These data support larger ...

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06163755

Comparison of Efficacy of Intra-articular Morphine vs ... Comparison of Efficacy of Intra-articular Morphine vs Methylprednisolone in Patients With Knee Osteoarthritis. A Single - Blind, Randomized-controlled Study.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1743919118306265

Review Comparison of intra-articular hyaluronic acid and ... The present meta-analysis indicated that both HA and methylprednisolone were effective in reducing pain in knee OA and HA showed comparable effect to ...

5. journals.lww.com journals.lww.com/md-journal/fulltext/2018/04130/intra_articular_injection_of_methylprednisolone.8.aspx

Intra-articular injection of methylprednisolone for... : Medicine Intra-articular methylprednisolone injection was associated with an improved pain relief and physical function in patients with knee osteoarthritis.